Surgical Pembro +/- Olaparib w TMZ for rGBM

Conditions

• Glioblastoma
• Recurrent Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — DRUG
  Intravenous infusion
• Olaparib — DRUG
  Pill taken by mouth
• Temozolomide — DRUG
  Pill taken by mouth

Study Details

This research study is studying a combination therapy as a possible treatment for recurrent glioblastoma (GBM), a brain tumor that is growing or progressing despite earlier treatment. The names of the study interventions involved in this study are/is: * Pembrolizumab * Olaparib * Temozolomide (Temodar)

Key Dates

Start date

Oct 21, 2022

Status verified

Mar 2026

Primary completion

Aug 1, 2026

Completion

Mar 1, 2027

Study Design

Enrollment

78 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1 (Safety Lead In): pembrolizumab plus olaparib and temozolomide
  Following a 3 + 3 dose escalation design 6-18 participants will receive: * Olaparib 2x daily on Days 1-7 of each 21-day study cycle. * Temozolomide 1x daily on Days 1-7 of each 21-day study cycle. * Pembrolizumab on Day 1 of every other 21-day cycle (once every 6 weeks).
• Experimental: Cohort 2 (Surgical Cohort): Arm A - Pembrolizumab plus olaparib and temozolomide
  Cohort 2 participants will be randomized into either group a or b (1:1): Group A participants will receive pembrolizumab, olaparib, and temozolomide before and after surgery. * Olaparib 2x daily on Days 1-7 of each 21-day study cycle. * Temozolomide 1x daily on Days 1-7 of each 21-day study cycle. * Pembrolizumab on Day 1 of every other 21-day cycle (once every 6 weeks).
• Experimental: Cohort 2 (Surgical Cohort): Arm B - Pembrolizumab monotherapy
  Cohort 2 participants will be randomized into either group a or b (1:1): Group B participants will receive pembrolizumab monotherapy before and after surgery. * Pembrolizumab Before Surgery: Day 1 of the pre-surgical treatment cycle. * Pembrolizumab After Surgery: Day 1 of every other 21-day cycle (once every 6 weeks).

Primary Outcome Measure

Tumor infiltrating lymphocytes (TIL) Density [ Time Frame: At surgery. Surgery will occur 14 days +/- 5 days after initiation of treatment. ]

Central Contacts

• Luis N Gonzalez Castro, MD
  617-732-7432
  [email protected]
• Christine J McCluskey
  (617) 632-5394
  [email protected]

Locations (4)

Find similar trials in Boston, MA

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